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NCT Number: NCT06729788

Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars

The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.

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Key information

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salsabeel M Abdelgaffar

Tanta, ELGharbia, 31527, Egypt

Location contact

Ahmed I El Dosoky, Assistant Professor

SUB_INVESTIGATOR

Fatma A El-Hendawy, Professor

SUB_INVESTIGATOR

Salsabeel M Abdelgaffar, B.D.S

CONTACT

[email protected]

+20 11 17010546

About this study

Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of the children from 6 to 8 years.
  • Healthy children free from any systemic disease.
  • Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
  • The eruption time of these molars should not exceed 3 years.
  • No sign of pain or active periodontal disease in the selected teeth.

Exclusion criteria

  • Children with fillings or sealants in the selected teeth.
  • Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
  • Children with an allergy to any drug, such as resin restorative material.
  • Children with Extremely poor oral hygiene.
  • Hypoplastic teeth.
  • Children with bruxism.

Treatment and study plan

ICON resin infiltration Material group in vivo

Drug

The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).

Resin-based fissure sealant group in vivo

Drug

The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)

ICON resin infiltration in vitro

Drug

The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro

Resin-based fissure sealant in vitro

Drug

The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro

Primary outcomes

  1. Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.

    Time frame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months

    172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.

Secondary outcomes

  1. Evaluate and compare the microleakage and penetration depth of the two sealant materials

    Time frame: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months

    20 teeth will be randomly assigned into two equal experimental groups . Experimental Group I: The fissure of selected teeth will be sealed with ICON resin infiltration. Experimental Group II: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).

    After removal from the dye teeth will be rinsed with water, cleaned, and sectioned longitudinally through the center of the restorations in a buccolingual direction with a double-sided diamond disc and will be given a code number to permit blind evaluation. For each specimen, the dye penetration along the buccal and lingual margins on each sectioned surface will be digitally photographed at 10x under a stereomicroscope. The degree of microleakage was scored by a single observer.

Study contacts

Contact information is provided by the study sponsor or research team.

Salsabeel M Abdelgaffar, B.D.S

CONTACT

[email protected]

+20 11 17010546

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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